PEG3350 vs Senna for Constipation

Overseen By Keila S Muniz, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: St. Joseph's Health, New York

Disqualifiers: Bowel surgery, Sacral neuromodulation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

254 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are: What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of constipation, vs those taking senna in the week after urogynecologic surgery? What patient-level and procedure-level characteristics are associated with postoperative ODS, in patients taking PEG3350 vs senna? participants will: Take their randomized medication daily for seven days after surgery Fill out an ODS questionnaire before and one week after surgery Complete a daily bowel diary for 7 days after surgery

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Polyethylene glycol 3350 for constipation?

Research shows that Polyethylene glycol 3350 is effective in treating chronic constipation in both children and adults, as it helps soften stools and improve bowel movements. ^{1 2 3 4 5}

Is PEG3350 safe for treating constipation?

Polyethylene glycol 3350 (PEG3350) is generally considered safe for treating constipation in both children and adults, as shown in various studies. It has been used safely for chronic constipation and bowel preparation, with no major safety concerns reported. ^{1 6 7 8 9}

How does PEG 3350 differ from other constipation drugs?

PEG 3350 is unique because it effectively reduces colonic transit time (the time it takes for food to move through the colon) and is safe for children, making it a good alternative to other laxatives like lactulose. It is also used for bowel preparation before procedures like colonoscopy, highlighting its versatility. ^{7 10 11 12 13}

Research Team

Keila S Muniz, MD

Principal Investigator

St. Joseph's Health

Eligibility Criteria

This trial is for individuals experiencing constipation after urogynecologic surgery. Participants will take a daily medication for seven days post-surgery and keep track of their bowel movements. They must be willing to fill out questionnaires before and after the treatment period.

Exclusion Criteria

I am having surgery for bowel issues or getting a sacral neuromodulation device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either PEG3350 or Senna for 7 days after urogynecologic surgery

1 week

Daily medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of a bowel diary and ODS questionnaire

1 week

1 visit (in-person) for follow-up assessment

Treatment Details

Interventions

• Polyethylene glycol 3350
• Senna

Trial Overview The study compares two laxatives: PEG3350 and senna, to see which is more effective at preventing obstructive defecation syndrome (ODS) following urogynecologic surgery. Patients are randomly assigned one of these medications and monitored for a week.

Participant Groups

Group I: Senna Experimental Treatment 1 Intervention

Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days

Group II: Polyethylene Glycol 3350 Active Control 1 Intervention

Polyethylene Glycol 3350, oral, 17g, daily for 7 days

Who Is Running the Clinical Trial?

St. Joseph's Health, New York

Lead Sponsor

Trials

1

Recruited

250+

References

1. England pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and optimal dose of daily polyethylene glycol 3350 for treatment of constipation and encopresis in children. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Trends in utilization and off-label use of polyethylene glycol 4000 laxatives and the prevalence of constipation in children in France. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Tolerance and Efficacy of Polyethylene Glycol 4000 in Elderly Patients with Chronic Constipation: A Retrospective, Single-center, Observational Study. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term safety of PEG 4000 in children with chronic functional constipation: A biochemical perspective. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

One-day bowel preparation with polyethylene glycol 3350: an effective regimen for colonoscopy in children. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Effects of polyethylene glycol 4000 on 24-h manometric recordings of left colonic motor activity. [2022]

12. England pubmed.ncbi.nlm.nih.gov

PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. [2018]

13. Greece pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 4000 treatment for children with constipation: A randomized comparative multicenter study. [2021]